Biomea Fusion Icovamenib Phase 2 COVALENT-112 (April 27): 52% C-Peptide AUC Increase at Week 12 in Recently-Diagnosed Type 1 Diabetes, Sustained Through Week 52
Biomea Fusion announced April 27 positive 52-week Phase 2 COVALENT-112 results in newly diagnosed type 1 diabetes. Patients diagnosed within 0–3 years dosed with icovamenib 200 mg once daily for 12 weeks showed a 52% increase in mean C-peptide AUC at Week 12 (p<0.001, n=5), with persistence through Week 52 (only ~7% decline from baseline) following just 12 weeks of dosing. C-peptide preservation was also observed in patients diagnosed 3–15 years prior (n=9). Icovamenib, a covalent menin inhibitor, was generally well tolerated with no new safety signals. Biomea is planning a Phase 2 expansion at four US academic centers in H2 2026 evaluating extended dosing (6 or 12 months) at 200 mg, with potential addition of an immunosuppressive agent. The data shifts attention back to beta-cell preservation as a T1D therapeutic strategy.